An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months

NCT ID: NCT00792103

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-09-30

Brief Summary

The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by:

• Subject self-examination skin irritation scores
• Adverse events
• Changes in vital signs and ECG parameters

The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:

• Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101
• Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101
• Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101
• Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
• Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
• Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101

This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch).

Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NP101

sumatriptan iontophoretic transdermal patch

Group Type: EXPERIMENTAL

NP101

Intervention Type: DRUG

NP101 study patch 4 hour application

Interventions

NP101

NP101 study patch 4 hour application

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject was previously enrolled in study NP101-007 and treated (patch activation) a qualifying migraine.
• Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, and ECG. Subjects will not have any clinically significant abnormal vital signs or ECG parameters in order to qualify for enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final Visit of study NP101-007 was conducted within 30 days.
• Female subjects of childbearing potential (not surgically sterile or 2 years post menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria

• Subject has less than two potential skin application sites.
• Subject has clinically significant abnormal vital signs or ECG parameters or had an adverse event while participating in NP101-007 that would preclude the continued treatment with the NP101 patch.
• Subject has had changes in their medical history or medication use that would preclude their use of sumatriptan as per the approved Imitrex® product Prescribing Information (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure.
• Subject has or plans to start, stop, change treatment or dose of any of the following within 3 months prior to the subject's study Enrollment date and through the Final Visit: anxiolytics, lithium and other mood stabilizers such as valproate, carbamazepine or lamotrigine, hypnotics or antipsychotics.
• Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations containing St. John's Wort within 1 month prior to enrollment and/or is planning to start any of these medications during the study (through Final Visit).
• Female subjects who are pregnant, breast feeding, or of childbearing potential, and are not using or are unwilling to use an effective form of contraception during the study and for a period of 30 days following Final Visit. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable.
• Subject has participated in a clinical study within 30 days of enrollment (excluding NP101-007) or is planning to participate in another clinical study for the duration of NP101-008.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuPathe Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Pierce, MD PhD

Role: STUDY_CHAIR

NuPathe Inc.

Locations

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Newport Beach, California, United States

San Francisco, California, United States

Santa Monica, California, United States

Fairfield, Connecticut, United States

Ocala, Florida, United States

Palm Beach Gardens, Florida, United States

Sunrise, Florida, United States

Atlanta, Georgia, United States

Columbus, Georgia, United States

Decatur, Georgia, United States

Savannah, Georgia, United States

Chicago, Illinois, United States

Ann Arbor, Michigan, United States

Kalamazoo, Michigan, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Mount Vernon, New York, United States

Plainview, New York, United States

Greensboro, North Carolina, United States

West Chester, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Wynnewood, Pennsylvania, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Alexandria, Virginia, United States

Virginia Beach, Virginia, United States

Seattle, Washington, United States

Countries

United States

References

Smith TR, Goldstein J, Singer R, Pugach N, Silberstein S, Pierce MW. Twelve-month tolerability and efficacy study of NP101, the sumatriptan iontophoretic transdermal system. Headache. 2012 Apr;52(4):612-24. doi: 10.1111/j.1526-4610.2012.02094.x. Epub 2012 Feb 21.

Reference Type: DERIVED

PMID: 22352764 (View on PubMed)

Other Identifiers

PROT-15-NP101-008

Identifier Type: -

Identifier Source: org_study_id